In August 2024 Ultimovacs announced topline data from the FOCUS Phase II trial combining UV1 and pembrolizumab in patients with metastatic or recurrent head and neck squamous cell carcinoma, revealing that the combination did not meet primary or secondary endpoints. Although the vaccine “continues to show a positive safety profile”, adding it to the standard of care did not lead to clinical benefits in progression free survival or overall survival in late-stage HNSCC patients. Head and neck cancer is the seventh most common type of cancer globally, with squamous cell carcinoma representing about 90% of those patients.
“Despite advances in treatment strategies, the prognosis for these patients is poor.”
UV1
UV1 is Ultimovacs’ therapeutic cancer vaccine, designed to induce a specific T cell response against telomerase. It comprises long, synthetic peptides representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), which is shown to induce CD4+ T cells. After intradermal injection, antigen presenting cells (APCs) in the skin are exposed to vaccine peptides. The APCs process the peptides and present vaccine epitopes on Human Leukocyte Antigen (HLA) molecules to naïve T cells in the lymph nodes.
FOCUS
The trial is an investigator-initiated randomised Phase II clinical trial, sponsored by Martin-Luther-University Halle-Wittenberg with support from Ultimovacs, taking place across 10 sites in Germany. It investigates Ultimovacs’ therapeutic cancer vaccine, UV1, in combination with pembrolizumab, compared to pembrolizumab alone, as a first-line treatment in patients with recurrent PD-L1 positive head and neck squamous cell carcinoma (HNSCC). The primary endpoint is progression free survival at 6 months.
A disappointing result
Dr Carlos de Sousa, Chief Executive Officer at Ultimovacs, reflected that the cancer vaccine has been tested in a “range of different indications” through a “broad Phase II clinical development programme”.
“Unfortunately, the FOCUS study did not provide us with the results we had hoped for, and we are disappointed that UV1 was not able to provide added clinical benefit for these HNSCC patients.”
Dr de Sousa stated that a cash preservation programme, implemented earlier in the year, enabled the team to “extend our runway” to the fourth quarter of 2025, beyond the anticipated DOVACC Phase II topline readout.
“Further, the Ultimovacs team is actively developing a novel technology platform identified during the TET development and we look forward to providing more details before year-end.”
Dr Jens Bjørheim, Ultimovacs’ Chief Medical Officer, echoed Dr de Sousa’s disappointment that the FOCUS trial “did not achieve the desired outcome for patients”, adding that this “underscores the complexities of treating metastatic and recurrent head and neck cancer”.
“This cancer type is particularly aggressive with limited treatment options and high rates of recurrence. Our broad clinical development programme was designed to identify the best patient populations for UV1 and we are now focusing our efforts on the upcoming DOVACC data readout in the first half of next year.”
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